Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03815188
Other study ID # STH20529
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2019
Est. completion date August 31, 2019

Study information

Verified date August 2019
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective study will be performed in the Cardiothoracic (Chesterman) Department at Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients undergoing surgical valvular intervention, breathing both spontaneously and mechanically will be included in the trial. All patients will already have a central venous catheter inserted as part of their ongoing care. Patients will be eligible for the study irrespective of diagnosis or neck size. Patient demographical data will be recorded by Sam Jenkins following written consent, the day before the trial.

The goal of this study is to determine if ultrasound assessment of Jugular Venous Pressure (JVP) accurately predicts Central Venous Pressure (CVP). Secondary objectives aim to identify if using the angle of Louis to approximate the location of the right atrium produces inaccuracies when measuring JVP. Comparing results in patients breathing spontaneously or under positive pressure ventilation will identify if the form of ventilation impacts on JVP and CVP recording. Correlating results between physical JVP examination and ultrasound assessment of JVP to measure CVP will conclude if ultrasound is a more appropriate tool, in an era where the physical examination of the cardiovascular system is becoming less valuable.


Description:

Initial exploratory investigations will compare left-sided and right-sided Jugular Venous Pressure (JVP) using ultrasonography. Should results show that they are the same, the central line is to be placed into the right internal jugular vein when required.

To begin the trial and whilst the patient is spontaneously breathing, a physical examination of the right JVP will be performed. A central line will be inserted with the patient awake into the right internal jugular vein. Left-sided ultrasound of JVP and Central Venous Pressure (CVP) will be measured using the right-sided catheter will be recorded simultaneously. The tip of the catheter attached to the transducer (which is zeroed to the reference point) will be placed at the point of venous collapse, identified by ultrasonography, to identify if the JVP and CVP match. The tip of the catheter will then be placed at the angle of Louis. Measurement of the pressure difference between the angle of Louis and the reference point will identify if this value shows variability compared to previous approximations of 5cm above the right atrium. With the patient anaesthetised and mechanically breathing, left JVP and CVP will be measured once more. Twenty-four hours post-surgery, ultrasound of the JVP and CVP will be measured with the patient breathing spontaneously.

The physical JVP examination will be recorded from the opposite side to the central venous catheter. The bed will be adjusted to an angle between 30 and 60 degrees, that most clearly identifies the collapsing vein. Differentiation between the JVP and the carotid pulse must be distinguished. Tangential lighting using a flashlight should be used to correctly identify and note the apex of the jugular venous pulsations. Recordings will be taken at end-expiration allowing the vertical distance between the venous meniscus and phlebostatic axis to be measured. JVP will be measured in millimetres of water.

Ultrasound recordings will be made using the SonoSite ultrasound probe by Sam Jenkins. The equipment and gels required are used routinely on site and will be supplied by Sheffield Teaching Hospitals. The SonoSite probe will be calibrated prior to each use, based on the recommendations of the manufacturer. The angle of the bed is kept constant and the patient will remain in the same position following the physical JVP examination. Ultrasound gel will be applied, again on the opposite side to the central venous catheter. Locating the area of venous collapse will be identified following visualisation from both longitudinal and transverse planes. The apex of venous collapse at end-expiration will be marked using the longitudinal view. Corroboration of the correct position of the probe by looking at the transverse view will be performed prior to marking of venous collapse.

CVP will be measured once the central venous catheter has been zeroed. The reference point of the transducer will be placed at the 4th intercostal space, mid-axillary line. The bed should still be kept at a constant angle for this measurement. The mean of the 'a' wave upon end-expiration will be taken. Converting the CVP from millimetres of mercury to millimetres of water will allow direct comparison to prior findings of JVP.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date August 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing cardiac surgery

- Patients who have a central line inserted during surgery

- Patients able and willing to give consent in verbal and written English.

Exclusion Criteria:

- Patients under the age of 18

- Patients unable to provide consent in verbal and written English

- Patients with thyroid enlargement or alternative reason causing obstruction to venous anatomy

- Patients with significant tricuspid regurgitation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Sheffield Teaching Hospitals NHS FT Sheffield England

Sponsors (2)

Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. Epub 2007 Apr 18. — View Citation

Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. — View Citation

Deol GR, Collett N, Ashby A, Schmidt GA. Ultrasound accurately reflects the jugular venous examination but underestimates central venous pressure. Chest. 2011 Jan;139(1):95-100. doi: 10.1378/chest.10-1301. Epub 2010 Aug 26. — View Citation

Fletcher RH, Fletcher SW. Has medicine outgrown physical diagnosis? Ann Intern Med. 1992 Nov 1;117(9):786-7. — View Citation

Jang T, Aubin C, Naunheim R, Char D. Ultrasonography of the internal jugular vein in patients with dyspnea without jugular venous distention on physical examination. Ann Emerg Med. 2004 Aug;44(2):160-8. — View Citation

Lipton B. Estimation of central venous pressure by ultrasound of the internal jugular vein. Am J Emerg Med. 2000 Jul;18(4):432-4. — View Citation

Mangione S, Nieman LZ. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. JAMA. 1997 Sep 3;278(9):717-22. Erratum in: JAMA 1998 May 13;279(18):1444. — View Citation

Seth R, Magner P, Matzinger F, van Walraven C. How far is the sternal angle from the mid-right atrium? J Gen Intern Med. 2002 Nov;17(11):852-6. — View Citation

Socransky SJ, Wiss R, Robins R, Anawati A, Roy MA, Yeung IC. Defining normal jugular venous pressure with ultrasonography. CJEM. 2010 Jul;12(4):320-4. — View Citation

Sondergaard S, Parkin G, Aneman A. Central venous pressure: we need to bring clinical use into physiological context. Acta Anaesthesiol Scand. 2015 May;59(5):552-60. doi: 10.1111/aas.12490. Epub 2015 Feb 13. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasonography Ultrasonography is expected to be a more accurate measure of CVP compared to physical JVP examination and is hypothesised to accurately predict CVP. Through study completion - 30/09/2019
See also
  Status Clinical Trial Phase
Completed NCT03079830 - Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery N/A
Completed NCT02278666 - Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry
Recruiting NCT02627391 - Early Surgery for Patients With Asymptomatic Aortic Stenosis N/A
Completed NCT03667235 - 10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure